Indicators of therapeutic effect in FIT-06, a Phase II trial of a DNA vaccine, GTU®-Multi-HIVB, in untreated HIV-1 infected subjects

► FIT GTU®-multi-HIVB was the first therapeutic HIV-1 vaccine trial conducted in South Africa. ► This plasmid DNA vaccine is safe and well-tolerated in HIV-1 infected, anteretrovial naive subjects. ► Cross subtype reactivity of subtype B derived vaccine in subtype C infected subjects was shown. ► Significant CD4 increases and VL decreases after IM vaccine were maintained for more than 2 years. ► This DNA HIV vaccine may be used as affordable prime/boost regimens alone or as an adjunct to HAART.